Group | Time | Seroconversion rate | Seroconversion factor | Seroprotection rate |
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| point | N | % | (95% CI) | N | Ratio | (95% CI) | N | % ≥1:40 | (95% CI) |
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Q-Pan0.9 | Pre | - | - | - | - | - | - | 76 | 36.8 | (26.1; 48.7) |
Day 21 | 76 | 98.7 | (92.9; 100) | 76 | 25.7 | (20.7; 32.0) | 76 | 98.7 | (92.9; 100) |
Month 6 | 73 | 63.0 | (50.9; 74.0) | 73 | 6.6 | (5.4; 8.2) | 73 | 75.3 | (63.9; 84.7) |
D-Pan0.9 | Pre | - | - | - | - | - | - | 75 | 32.0 | (21.7; 43.8) |
Day 21 | 75 | 98.7 | (92.8; 100) | 75 | 27.1 | (22.4; 32.8) | 75 | 98.7 | (92.8; 100) |
Month 6 | 74 | 71.6 | (59.9; 81.5) | 74 | 8.0 | (6.4; 10.1) | 74 | 85.1 | (75.0; 92.3) |
Q-Pan1.9 | Pre | - | - | - | - | - | - | 58 | 31.0 | (19.5; 44.5) |
Day 21 | 58 | 98.3 | (90.8; 100) | 58 | 32.2 | (24.7; 42.0) | 58 | 98.3 | (90.8; 100) |
| Month 6 | 58 | 69.0 | (55.5; 80.5) | 58 | 8.9 | (6.8; 11.7) | 58 | 79.3 | (66.6; 88.8) |
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N number of subjects with available results (for seroconversion rate and seroconversion factor N - the number of subjects with pre- and post-vaccination results available); % - percentage of subjects; 95% CI - 95% confidence interval. Seroconversion: For initially seronegative subjects (i.e., HI titres <1:10), antibody titre≥ 1:40 after vaccination. For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre. Seroconversion Factor - Geometric Mean Ratio (mean[log10(post-vaccination GMT/pre vaccination GMT]). Pre - prior to vaccination, Day 21 etc- 21 days post vaccination. CBER Criteria were fulfilled if: the lower limit of the 95% CI for SCR was >40%, and the lower limit of the 95% CI for % ≥1:40 was > 70%. CHMP Criteria were fulfilled if: the point estimate for SCR was > 40% and, the post-vaccination point estimate for % ≥1:40 was > 70% and, the point estimate for SCF was >2.5. See Table 1 for details of treatment groups.